Drugs

Epcoritamab Combo for Relapsed Follicular Lymphoma OK’d

FDA has approved Genmab’s Epkinly (epcoritamab-bysp) for combination with lenalidomide and rituximab in adults with relapsed or refractory follicular lymphoma (FL), expanding treatment options for one of the most common indolent B-cell lymphomas. The agency action also converted the drug’s 2024 accelerated approval for third-line FL into a full, traditional approval, allowing epcoritamab to be used as a standalone therapy after two or more prior systemic treatments.

The combination regimen’s approval was based on data from the Phase 3 EPCORE FL-1 trial, which enrolled 488 patients with relapsed or refractory FL who had received a median of one prior line of therapy, according to an FDA notice. Nearly one-quarter had undergone at least two prior treatments.

Patients were randomized to receive either epcoritamab plus lenalidomide and rituximab or the standard lenalidomide and rituximab regimen alone. FDA says the study demonstrated a dramatic improvement in progression-free survival (PFS):

PFS hazard ratio: 0.21 (79% reduction in risk of progression or death)
Overall response rate: 89% with the epcoritamab combination vs. 74% for standard

The agency notes that Epkinly’s updated prescribing information includes Boxed Warnings for cytokine release syndrome (CRS) and immune effector cell–associated neurotoxicity syndrome (ICANS), two known risks with T-cell–engaging bispecific antibodies. In the EPCORE FL-1 study:

CRS occurred in 24% of patients (serious CRS in 12%)
ICANS occurred in 0.8%
Serious adverse reactions occurred in 51% of patients receiving the epcoritamab regimen
Serious infections were reported in 28%

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome